CHARLES BRADANOV

Be careful what you use when building up your QMS system! The expanding Internet means more: more data, more collaboration, and more complex systems of interactions. You can find hundreds of both expensive and free templates for ISO 13485, offered by various consultants, companies and experts. But even if the ISO compliance is guaranteed on some...

In the world of standards, regulations and protocols it is really easy to get confused. They are complex and always changing. Often, the issue is in the details and details are easily missed. Then when you try to make things compliant, you have to constantly be on top of every little detail if you don't...

We are pleased to announce the release of the new team managing tool - My Team, in the Project Management Module for qmsWrapper. Projects are about teams, but the biggest project of all is managing your team. Announcing “My Team”, the newest element of qmsWrapper. “My Team” is a new module that gives managers the ability to...

QMS, another layer of management or smart management.  If you’re thinking that a QMS system would be just another layer of management, think again! It’s true that most QMS systems are form-driven. Do an action, fill-a-form. Make a meeting, fill-a-form? The list is endless and if you forget, which is easy to do when deadlines are knocking...

Successful startups and small businesses understand that although a DMS (Document Management Software) is essential to success it is outright critical for compliance. The top features requested in DM software reflect the growing needs of Startups and Small companies who cannot ignore the increasingly central role a DMS plays in their growth and success – both...

Differences and similarities between the ISO 13485:2003 and ISO 13485:2016 editions. ISO 13485:2003 only had a few defined terms with clear definitions. However, in the new edition of ISO 13485:2016, sixteen new terms are added with longer definitions. Let's see what are the differences and similarities between the editions. Terms that remained the same Advisory notice - giving...

May 2016 was a dark period for medical small companies and startups, it was the day the ISO created a glass ceiling for Medical Startups. A glass ceiling! Yes, because ISO13485:2016 essentially puts a glass ceiling on medical start-ups with a daunting new array certification requirements that will disproportionally impact startups and small companies. Essentially, to properly manage...

An innovative approach to tackle the challenges of modern business - Management Through Quality™ qmsWrapper is a smart management software that effectively avoids adding another layer of management by encouraging team-based collaboration compliance. qmsWrapper is for any company needing a powerful, unified platform to help the teamwork more effectively together. qmsWrapper provides the means for teams to...